November **, ****

J A M E S L. M A R T I N

CLAYTON, NC 508-***-****

E M T ac7ve5@r.postjobfree.com https:/ /w ww.linkedin.com/in/jamesmartinnc O B J E C T I V E

To utilize and expand my skills as a senior and/or management professional for software and hardware products/systems as they are applied in regulated, GxP environments. Over twenty years of hands-on experience in developing, implementing and monitoring various quality/validation programs for pharmaceutical, medical device and ISO certified companies will assure my success as a valuable project manager and/or team leader. S U MMARY

• Assuring the accuracy, precision, and reliability of computerized system data in local and cloud network environments. Implementation of Quality Management System (QMS) programs including the validation of Computer Systems in development environments and qualification of commercial off-the-shelf systems (COTS).

• Experience with traditional waterfall and Agile development methodologies.

• Development of, implementation, execution, and support of risk-based validation steps/phases.

• Supporting product/application processes including QMS documentation, training, corrective/preventative actions, internal and external auditing, controlled release processes and privacy and security policies.

• Assuring compliance to agency and industry regulations (and predicate rules) including (but not limited to) 21 CFR Parts 11, 50, 58, 203, 210, 211, 312, 314, 820 as well as ISO9000, AS9100, HIPAA and GDPR standards. Comprehensive knowledge of agency guidance documents related to computerized systems, pharmaceutical cGMPs, CFR 21 Part 11, ICH, among other relevant topics. Proficient with Good Automated Manufacturing Processes (GAMP5) and associated supplement guides. P R O F E S S I O N A L E X P E R I E N C E

AG MEDNET, INC., Boston, MA 2009 – Present

Senior Manager of Quality Assurance and Regulatory Compliance: Successfully developed, implemented and managed a Quality Management System (QMS) and Validation program for a core network and associated applications designed with functionality, support, and footprint necessary to collect clinical trial data globally and deliver it reliably and securely to one or more trial repositories. Achievements include:

• Launched an entire Quality Management System (QMS) including a software lifecycle development (SDLC) program based on ISO, ICH, Agile and GAMP5 methodologies meeting GxP Regulations.

• Implemented a Patient Privacy program meeting GxP, HIPAA and GDPR requirements including registration with Safe Harbor and Privacy Shield.

• Implemented a Security Information Policy Manual within the organization.

• Management of several concurrent Validation projects including staff and supporting resources.

• Management of internal audit program and hosting of external audits (75+) for clients comprised of the largest, global pharmaceutical companies, and Clinical Research Organizations such as IQVIA and ICON.

• Oversee training, documentation management, and corrective action process.

• Transitioned many of the above processes from paper-based to electronic paperless processes. SEPRACOR, INC., (now Sunovion, Inc.), Marlboro, MA 2007 – 2009 Senior Computer Systems Compliance Engineer:

In coordination with the business user community and Information Technology (IT) validated or assisted with the validation of commercial off the shelf (COTS) computerized systems for use in GLP and GCP environments. Major systems included:

Oracle Clinical (OC) – OC Database, Remote Data Capture, Thesaurus Management Adverse Events Reporting System

(AERS) Change Control Tracking Audit Tracking Regulatory Submissions Applications JAMES L. MARTIN Page 2

GULFSTREAM BIOINFORMATICS, Lexington, MA 2006 – 2007 Quality Assurance/Computer Systems Compliance Manager: Successfully developed, implemented and managed a compliance program for the design and development of web- hosted software applications to track the collection, registration, annotation, storage, and distribution of donor samples and associated clinical and pathology report data in the Life Sciences industry meeting GxP requirements. FOSTER-MILLER, INC., (Now QinetiQ), Waltham, MA 2002 – 2006 Pharmaceutical Quality Assurance Manager:

Managed various teams of Software Quality Assurance (SQA) test engineers and Quality Control (QC) engineers. Successfully developed and managed Quality programs for multi-million-dollar pharmaceutical automation projects with major pharmaceutical companies such as Pfizer in Groton, CT. Managed several client audits and associated follow-up activities. Several products validated and in use in regulated environments. Group Quality Assurance representative for a corporate effort to implement AS9100 and ISO9000 throughout the corporation and key contributor to the initial certification of the TALON® Robot. Corporate team “lead” responsible for interfacing with various group and corporate managers to author, train and maintain a corporate Design and Development Process. C O M P U T E R S K I L L S

Microsoft Office Products including Word, Excel, PowerPoint, Outlook, Project, PowerPoint, Access, and Visio Use and administration of Atlassian JIRA and Confluence Implementation and maintenance of Learning Management, Corrective Action, and Lifecycle Management Systems Working knowledge of Graphic Layout software including Corel Suite, Adobe Suite, and Microsoft Publisher General knowledge of computer architecture including database and networking experience.

E D U C A T I O N

Wentworth Institute of Technology, Boston, MA, AS in Engineering Technology w/ Honors (Magna Cum Laude GPA 3.62).

Framingham State College, Framingham, MA, Earned 60 Credits toward a BS in Business Administration. Rational University, Lexington, MA, Coursework included Rational Unified Process (RUP), Modeling using Rose, Requirements Management using Requisite Pro, Change Management using Clear Case, Defect Management using Clear Quest.

Pharmaceutical Training Institute, New York, NY, Completed Certificate Programs in Pharmaceutical Quality Assurance and Pharmaceutical Validation.

American Management Association, New York, NY, Seminars in Management Practices M EMBERSHIPS

Member, Institute of Validation Technology, Royal Palm Beach, FL Member, American Management Association, New York, NY Member, American Society for Quality (ASQ), Boston and Worcester Section A F F I L I A T I O N S & C O MMUNITY I N V O L V EMENT Member, Thanksgiving Volunteer Fire Dept

North Carolina Certified Advanced Emergency Medical Technician (EMT-I), 1997 Fire Ground Command and Pre-Hospital Emergency Care Massachusetts Firefighter Level I and II Certification Training, 1998 – 2000 North Carolina Firefighter Certification (Johnston Community College) 2016 - Present American Heart Association Certified CPR/First Aid Instructor Trainer, 2000

Contact this candidate